MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas alleging the patient¿s blood glucose that day was 519 mg/dl with nausea.The reporter noted the patient did not receive any treatment above and beyond the usual routine of diabetes care and management, they discontinued pump therapy, and the pump¿s delivery settings were not recently changed by a healthcare provider.It was reported that the patient had discontinued pump therapy due to a battery life issue and did not treat their diabetes with a backup plan.This complaint is being reported because the health event was attributed to an alleged device malfunction.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 9/21/2017 with the following findings: a review of the pump¿s black box data showed no evidence of a short battery life.During visual inspection of the pump, it was observed that the returned battery cap was undamaged and was able to fit to the pump and maintain an electrical connection.The pump¿s ¿ez-prime¿ steps were performed correctly and all of the pump¿s electrical current draws measured within specifications.The total daily doses added up correctly and reflected the user¿s programmed basal rates.The pump passed a delivery accuracy test and was found to be operating within required specification and delivery accurately.The investigation was unable to duplicate the original ¿short battery life¿ complaint.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 6776657
• Report Number: 2531779-2017-17843
• Device Sequence Number: 831810
• Product Code: LZG
• UDI-Device Identifier: 10840406101126
• UDI-Public: 0110840406101126
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 21 MO
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR